[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"huntingtons-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:huntingtons-disease":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,41,71,99,122,161],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":5},"100611927","phase-1-a-study-to-evaluate-the-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-rg6496-in-huntingtons-disease-100611927",false,"NCT07246941","A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RG6496 in Huntington's Disease","A Phase I, 2-Part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single-ascending Doses of Intrathecally Administered RG6496 in a Randomized, Placebo-controlled, Investigator\u002FParticipant-blind Study With an Open-label Extension in Huntington's Disease Gene Expansion Carriers","POINT-HD","Inclusion Criteria:\n\nPart 1\n\n* Confirmation of HDGEC status with cytosine-adenine-guanine (CAG) expansion \\> 39.\n* Confirmation of SNP carrier status of the target SNP\n* Independence Scale (IS) score of ≥70, total functional capacity (TFC) ≥10, total motor score (TMS) \\>6.\n* Ability to read the words \"red,\" \"blue,\" and \"green\" and be fluent in the language of the informed consent form (ICF) and the tests used at the study site.\n* Ability to walk unassisted.\n* Total body weight \\> 40 kilogram (kg) and body mass index (BMI) within the range 18-32 kilogram per square meter (kg\u002Fm\\^2) (inclusive) at baseline.\n* Ability to undergo and tolerate MRI scans.\n\nPart 2\n\n* Completed the post-dose safety follow-up period in the Part 1 of the study.\n* In the opinion of the Investigator, the participant has not experienced a worsening in health that precludes their safe continued participation in the study.\n\nExclusion Criteria:\n\nPart 1\n\n* Concurrent or planned participation in any interventional clinical study, including current use of an ASO or any HTT-lowering therapy or treatment with investigational therapy within 90 days or 5 drug-elimination half-lives, whichever is longer prior to screening\n* Pregnant or breastfeeding, or with the intention of becoming pregnant during the study or within the timeframe in which contraception is required\n* Malignancy within 5 years prior to screening\n* Planned brain surgery during the study\n* Positive HIV test, hepatitis B surface antigen and hepatitis B surface antigen at screening\n* Active psychosis, confusional state, or violent behavior, including aggression that could cause harm to self or others, over the 12 weeks prior to screening.\n* Current or previous history of a primary independent psychotic disorder.\n* Scoliosis or spinal deformity or surgery making IT injection not feasible in an outpatient setting\n* History of attempted suicide or suicidal ideation with plan (i.e., active suicidal ideation) that required hospital visit and\u002For change in level of care within 12 months prior to screening.\n\nPart 2\n\n* Prematurely discontinued from Part 1 for any reason (i.e., before the completion of the postdose safety follow-up period of Part 1).\n* Pregnant or breastfeeding, or with the intention of becoming pregnant during the study or within the timeframe in which contraception is required.\n* Concurrent or planned participation in any interventional clinical study, including current use of an ASO or any HTT-lowering therapy\n* Received any active investigational treatment other than RG6496 during or since completion of Part 1 of the study.\n* Had confirmed Dose-Limiting Adverse Event (DLAE)(s) in Part 1 of the study.","ALL","25 Years","65 Years",{"count":21,"type":22},40,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This is a first-in-human (FIH) study of RG6496 that will assess the safety and tolerability of single-ascending doses of RG6496 administered to huntington's disease gene expansion carriers (HDGECs). The study consists of two parts: Part 1 \\[single-ascending dose\\] followed by Part 2 \\[open-label extension (OLE)\\].",[28],"Huntington's Disease","RECRUITING","2026-06-26",{"date":32,"type":33},"2026-06-29","ACTUAL",{"date":35,"type":33},"2025-11-19",{"date":37,"type":22},"2029-05-23",{"name":39,"class":40},"Hoffmann-La Roche","INDUSTRY",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":23,"phases":51,"briefSummary":52,"conditions":53,"keywords":54,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":70},"100561076","phase-1-a-study-to-evaluate-aln-htt02-in-adult-patients-with-huntingtons-disease-100561076","NCT06585449","A Study to Evaluate ALN-HTT02 in Adult Patients With Huntington's Disease","A Randomized, Double-blind, Placebo-controlled Study, to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intrathecally Administered Single Ascending Doses of ALN-HTT02 in Adult Patients With Huntington's Disease","Inclusion Criteria\n\n* Has stage 2 or early Stage 3 Huntington's disease (HD), per the Huntington's Disease Integrated Staging System (HD-ISS)\n\nExclusion Criteria\n\n* Has significant structural or degenerative neurologic disease other than Huntington's Disease (HD) at screening\n* Has primary or secondary immune compromise at screening due to infections, medical conditions, or chronic therapies\n* Has alanine aminotransferase or aspartate aminotransferase \\>2× upper limit of normal (ULN)\n* Has an estimated glomerular filtration rate (eGFR) of \\\u003C60 mL\u002Fmin\u002F1.73m\\^2 at screening\n* Has received an investigational agent within the last 1 year or 5 half-lives (if known)\n\nNote: other protocol defined inclusion \u002F exclusion criteria apply","70 Years",{"count":50,"type":22},66,[25],"The purpose of this study is to evaluate the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of single or repeat doses of ALN-HTT02.",[28],[55,56,57,58,59,60],"siRNA","ALN-HTT02","Intrathecal","HD-ISS Stage 2","HD-ISS early Stage 3","Neurodegenerative disorder","2026-06-10",{"date":63,"type":33},"2026-06-12",{"date":65,"type":33},"2024-10-14",{"date":67,"type":22},"2028-07-05",{"name":69,"class":40},"Alnylam Pharmaceuticals",19,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":17,"minAge":78,"maxAge":48,"enrollmentInfo":79,"targetDuration":4,"studyType":23,"phases":81,"briefSummary":82,"conditions":83,"keywords":84,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":98},"100634159","phase-1-a-first-in-human-study-of-the-effects-of-srp-1005-in-participants-with-huntingtons-disease-100634159","NCT07536061","A First-in-human Study of the Effects of SRP-1005 in Participants With Huntington's Disease","A Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study to Evaluate the Effect of SRP-1005 in Subjects With Huntington's Disease (INSIGHTT)","Key Inclusion Criteria:\n\n* Genetically confirmed diagnosis of huntingtin (HTT) cytosine-adenine-guanine repeat length ≥40.\n* Participant has HD Integrated Staging System (HD-ISS) Stage 2 or Mild Stage 3. At screening, the participant must be classified with the Enroll-HD HD-ISS Modified Calculator as either Stage 2 or Mild Stage 3.\n* Participants who are of childbearing potential, or with partners of childbearing potential, who are sexually active must agree to use a highly effective method of contraception throughout study participation, and for at least 90 days following the end of study.\n\nKey Exclusion Criteria:\n\n* Any condition that would compromise the safety or feasibility of lumbar puncture or magnetic resonance imaging (MRI).\n* Presence of other significant neurological or systemic illnesses.\n* Current, chronic or active human immunodeficiency virus, hepatitis B\u002FC.\n* Recent use of investigational agents or HTT-lowering therapies.\n* Uncontrolled psychiatric illness or substance use disorders.\n* Pregnancy or lactation.\n\nNote: Other inclusion\u002Fexclusion criteria apply.","21 Years",{"count":80,"type":22},32,[25],"This is a first-in-human, multi-center trial studying the effects of SRP-1005 in participants with Huntington's disease (HD).",[28],[85,86,87,88],"Huntington's disease","SRP-1005","Dose Escalation","First in Human","2026-06-03",{"date":91,"type":33},"2026-06-04",{"date":93,"type":33},"2026-05-12",{"date":95,"type":22},"2027-11-30",{"name":97,"class":40},"Sarepta Therapeutics, Inc.",2,{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":106,"sex":17,"minAge":107,"maxAge":108,"enrollmentInfo":109,"targetDuration":4,"studyType":111,"phases":4,"briefSummary":112,"conditions":113,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":4,"leadSponsor":119,"locationsCount":21},"100274686","hdclarity-a-multi-site-cerebrospinal-fluid-collection-initiative-to-facilitate-therapeutic-development-for-huntingtons-disease-100274686","NCT02855476","HDClarity: a Multi-site Cerebrospinal Fluid Collection Initiative to Facilitate Therapeutic Development for Huntington's Disease","HDClarity","Inclusion Criteria:\n\n* Age (18-75 years controls, early\u002Flate premanifest HD and incomplete penetrance HD, 21-75 years early\u002Fmoderate\u002Fadvanced manifest HD, ≥11 years juvenile HD)\n* Enroll HD participant\n* Capable of consenting or have a legal representative (parent\u002Fguardian for juveniles)\n* Capable of complying with study procedures\n* All participants other than family and community controls must have had a genetic test for HD\n\nExclusion Criteria:\n\n* Drug trial within 30 days of any sampling visit\n* Changes in medication (antidepressant, psychoactive, psychotropic or other medications or nutraceuticals used to treat HD within 30 days)\n* Antiplatelet or anticoagulant therapy within 14 days\n* Significant comorbidity\n* Needle phobia, headache, spinal surgery \u002F deformity\n* Clotting or bruising disorder\n* Screening blood test abnormalities \\>10% outside normal range\n* Drug \u002F alcohol abuse\n* Positive urine pregnancy test at any screening or sampling visit for females of childbearing potential\n* Predictable non compliance or unwillingness\n* Serious adverse event related to HDClarity study procedures or any lumbar puncture procedure performed for any reason in the previous 30 days",true,"11 Years","75 Years",{"count":110,"type":22},2500,"OBSERVATIONAL","HDClarity will seek at least 2500 research participants at different stages of Huntington's disease (HD). The primary objective is to collect a high quality CSF sample for evaluation of biomarkers and pathways that will enable the development of novel treatments for HD. The secondary objective is to generate a high quality plasma sample collection matching the CSF collections, which will also be used to evaluate biomarkers and pathways of relevance to HD research and development.",[28],"2026-04-24",{"date":116,"type":33},"2026-04-27",{"date":118,"type":33},"2017-01-01",{"name":120,"class":121},"University College, London","OTHER",{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":106,"sex":17,"minAge":130,"maxAge":131,"enrollmentInfo":132,"targetDuration":4,"studyType":23,"phases":134,"briefSummary":136,"conditions":137,"keywords":146,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":160},"100564857","early-phase-1-imagemhtt-009--fih-evaluation-of-novel-mutant-huntingtin-pet-radioligand-11cchdi-00491009-100564857","NCT06634628","iMagemHTT-009- FIH Evaluation of Novel Mutant Huntingtin PET Radioligand [11C]CHDI-00491009","First in Human Adaptive Study to Investigate the Kinetic Properties of the Novel PET Radioligand [11C]CHDI-00491009 and Its Suitability for Quantification of Aggregated Mutant Huntingtin in the Brains of People With Huntington's Disease","iMagemHTT-009","Inclusion Criteria:\n\nPwHD HD-ISS Stages 2 and 3 and HC participants who:\n\n1. Are female or male adults, age 18-64 years old, inclusive.\n2. Have body mass index (BMI) between 19 and 35, inclusive.\n3. Have capacity to give full informed consent in writing and have read and signed the informed consent form (ICF).\n4. Are able to comply with study procedures, including fasting and blood sampling.\n5. Are able and willing to travel to the imaging center in Leuven, Belgium.\n6. Are willing to comply with the use of adequate contraceptive measures.\n\n   HD-ISS Stage 2 participants who:\n7. Have a huntingtin gene CAG expansion between 40 and 50, inclusive; and\n8. Are classified within HD-ISS Stage 2 per the HD-ISS criteria using HD-ISS Modified Stage calculator.\n9. Have a PIN score of 0.47 to 1.84 \\[prognostic index normed for HD (PIN) where PIN = (PIHD - 883)\u002F1044 where PIHD = 51 x TMS + (-34) x SDMT + 7 x Age x (CAG - 34) (TMS is the UHDRS Total Motor Score, and SDMT is the UHDRS Symbol Digit Modalities Test)\\].\n\nHD-ISS Stage 2 participants who:\n\n7\\. Have a huntingtin gene CAG expansion between 40 and 50, inclusive; and 8. Are classified within HD-ISS Stage 2 per the HD-ISS criteria using HD-ISS Modified Stage calculator.\n\n9\\. Have a PIN score of 0.47 to 1.84 \\[prognostic index normed for HD (PIN) where PIN = (PIHD - 883)\u002F1044 where PIHD = 51 x TMS + (-34) x SDMT + 7 x Age x (CAG - 34) (TMS is the UHDRS Total Motor Score, and SDMT is the UHDRS Symbol Digit Modalities Test)\\].\n\nHC participants who:\n\n13\\. Have no known family history of HD; or 14. Have a known family history of HD and have been tested for the huntingtin gene CAG expansion and are not at genetic risk for HD (CAG \\\u003C 36).\n\n15\\. Age match (+\u002F- 5 years) and biological sex match to each HD participant in Cohort 2 and Cohort 3 (except for Cohort 1, no matching).\n\nExclusion Criteria:\n\nPwHD HD-ISS Stages 2 and 3 and HC participants who:\n\n1. Are currently participating in, or are less than 30 days after completing participation in, other therapeutic or imaging studies.\n2. Have previously participated in a PET imaging study in the past 12 months that, cumulatively with the current study, will exceed annual regulatory limits for radiation exposure.\n3. Have any disease, condition, or concomitant medication that significantly compromises the function of the body systems and that, in the opinion of the Investigator, might interfere with the conduct of the study or its interpretation.\n4. Are pregnant and breastfeeding females.\n5. Have concomitant use of antiplatelet or anticoagulant therapy (inclusive of acetylsalicylic acid).\n6. Have a bleeding disorder.\n7. Have a needle phobia.\n8. Have any metal objects present in the body that are incompatible with MRI.\n9. Have metal objects present in the body that are compatible with MRI and are located in the head or neck.\n10. Have any clinically significant results on safety laboratory tests that, in the opinion of the Investigator, would either put the participant at risk or interfere with the conduct of the study or interpretation of data. These tests include, but are not limited to:\n\n    * a. positive results for HBsAg, HepC, HIV-1 or HIV-2 (will also be reported as required by local\u002Fnational regulations),\n    * b. clinically significant, abnormal results for safety laboratory tests.\n\n    PwHD participants who:\n11. If they are using any antidepressant, psychoactive, psychotropic or other medications or nutraceuticals used to treat HD, the use of inappropriate (e.g., non-therapeutically high) or unstable dose within 30 days prior to participation.\n\n    HC participants who:\n12. Have a family history of HD and have not been tested for the huntingtin gene (CAG) expansion.","18 Years","64 Years",{"count":133,"type":22},27,[135],"EARLY_PHASE1","This is a FIH (first-in-human) study to evaluate the clinical utility of the radioligand \\[11C\\]CHDI-00491009 as a PET tracer that binds specifically to mutant huntingtin (mHTT) aggregates in Huntington's disease (HD).\n\nThe study is divided into three cohorts defined by the Huntington's Disease Integrated Staging System (HD-ISS): Cohort 1 - initial tracer validation (3 healthy controls (HCs)); Cohort 2 - target validation and test-retest variability (6 HD-ISS Stage 3 participants and 6 age and biological sex-matched HCs); Cohort 3 - target sensitivity (6 HD-ISS Stage 2 participants and 6 age and biological sex-matched HCs). An interim analysis (IA) will be conducted after the completion of each cohort, followed by a final analysis for the study.\n\nIn addition to imaging, exploratory biomarkers, including somatic instability index, soluble mHTT and total huntingtin (HTT), will be assessed. All participants with HD (PwHD) will have an additional blood sample drawn at the screening visit to assess the somatic instability index and will also be invited to provide an optional cerebrospinal fluid (CSF) sample for measurement of soluble mHTT and total HTT.",[138,139,140,141,142,143,144,145,28],"Huntington Disease","HD","PET Tracer","Positron Emission Tomography","Radioligand","Imaging","mHTT","Huntington's",[147,138,139,140,141,148,149,144,150,28],"iMagemHTT","radioligand","imaging","huntingtin","2026-03-12",{"date":153,"type":33},"2026-03-13",{"date":155,"type":33},"2026-02-24",{"date":157,"type":22},"2028-03",{"name":159,"class":121},"CHDI Foundation, Inc.",1,{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":165,"acronym":4,"eligibilityCriteria":166,"healthyVolunteers":106,"sex":17,"minAge":130,"maxAge":4,"enrollmentInfo":167,"targetDuration":169,"studyType":111,"phases":4,"briefSummary":170,"conditions":171,"keywords":172,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":185},"100176679","enroll--hd-a-prospective-registry-study-in-a-global-huntingtons-disease-cohort-100176679","NCT01574053","Enroll -HD: A Prospective Registry Study in a Global Huntington's Disease Cohort","Inclusion Criteria:\n\n* Carriers: This group comprises the primary study population and consists of individuals who carry the HD gene expansion mutation.\n* Controls: This group comprises the comparator study population and consists of individuals who do not carry the HD expansion mutation.\n\nThese two major categories can be further subdivided into six different subgroups of eligible individuals:\n\n* Manifest\u002FMotor-manifest HD: Carriers with clinical features that are regarded in the opinion of the investigator as diagnostic of HD.\n* Pre-Manifest\u002F-Motor-manifest HD: Carriers without clinical features regarded as diagnostic of HD.\n* Genotype Unknown: This group includes a first or second degree relative (i.e., related by blood to a carrier) who has not undergone predictive testing for HD and therefore has an undetermined carrier status.\n* Genotype Negative: This group includes a first or second degree relative (i.e., related by blood to a carrier) who has undergone predictive testing for HD and is known not to carry the HD expansion mutation.\n* Family Control: Family members or individuals not related by blood to carriers (e.g., spouses, partners, caregivers).\n* Community Controls: Individuals unrelated to HD carriers who did not grow up in a family affected by HD. Data collected from community controls will be used for generation of normative data for sub-studies.\n\nParticipant status will be captured in the study database using 2 variables: 1) Investigator Determined Status: this will be based on clinical signs and symptoms and genotyping performed as part of medical care, and will be updated at every visit; and 2) Research Genotyping Status: this will be based on genotyping conducted as part of Enroll-HD study procedures. Based on research genotyping, participants will be reclassified under this variable from Genotype Unknown to 'Carriers' or 'Controls'. Investigators and participants will be blinded to this reclassification.\n\nExclusion Criteria:\n\n* Individuals who do not meet inclusion criteria,\n* Individuals with choreic movement disorders in the context of a negative test for the HD gene mutation.\n* For Community Controls: those individuals with a major central nervous system disorder will be excluded (e.g. stroke, Parkinson's disease, multiple sclerosis, etc.).\n\nParticipants under 18 may be eligible to participate (if they have juvenile-onset HD).",{"count":168,"type":22},35000,"1 Year","Enroll-HD is a longitudinal, observational, multinational study that integrates two former Huntington's disease (HD) registries-REGISTRY in Europe, and COHORT in North America and Australasia-while also expanding to include sites in Latin America. More than 30,000 participants have now enrolled into the study. With annual assessments and no end date, Enroll-HD has built a large and rich database of longitudinal clinical data and biospecimens that form the basis for studies developing tools and biomarkers for progression and prognosis, identifying clinically-relevant phenotypic characteristics, and establishing clearly defined endpoints for interventional studies. Periodic cuts of the database are now available to any interested researcher to use in their research - visit www.enroll-hd.org\u002Ffor-researchers\u002Faccess-data\u002F to learn more.",[28],[28,138,173,174,175,176],"Juvenile Huntington's Disease","Registry","Cohort","CHDI","2024-02-26",{"date":179,"type":33},"2024-02-28",{"date":181,"type":33},"2012-07",{"date":183,"type":22},"2062-01",{"name":159,"class":121},183]